Back to resultsLow-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
low dose combination of MMF and Tac
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring lupus, nephritis, glomerulonephritis, nephropathy, refractory
Eligibility Criteria
Inclusion Criteria:
- Active nephritis documented by renal biopsy within 24 months of entry;
- Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
- Serum creatinine (Scr) less than 200umol/L.
Exclusion Criteria:
- Previous intolerance to either MMF/Tac;
- Scr >200umol/L;
- Informed consent unavailable.
Sites / Locations
- Tuen Mun Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combination treatment
Arm Description
treatment arm
Outcomes
Primary Outcome Measures
Clinical remission rate
Secondary Outcome Measures
Adverse events
adverse events experienced by patients as a measure of tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01203709
Brief Title
Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis
Official Title
Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tuen Mun Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A trial of combination of two drugs for the treatment of refractory lupus nephritis.
Detailed Description
Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
lupus, nephritis, glomerulonephritis, nephropathy, refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination treatment
Arm Type
Experimental
Arm Description
treatment arm
Intervention Type
Drug
Intervention Name(s)
low dose combination of MMF and Tac
Other Intervention Name(s)
Cellcept and Prograf
Intervention Description
mycophenolate mofetil 500mg BID + tacrolimus 2mg BID
Primary Outcome Measure Information:
Title
Clinical remission rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse events
Description
adverse events experienced by patients as a measure of tolerability
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active nephritis documented by renal biopsy within 24 months of entry;
Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
Serum creatinine (Scr) less than 200umol/L.
Exclusion Criteria:
Previous intolerance to either MMF/Tac;
Scr >200umol/L;
Informed consent unavailable.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CC Mok, MD, FRCP
Organizational Affiliation
Tuen Mun Hospital, Hong Kong China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis
We'll reach out to this number within 24 hrs